Veterinary Medicines

ATOPICA 10 mg soft capsules for dogs

Not authorised
  • Ciclosporin
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Product identification

Medicine name:
ATOPICA 10 mg soft capsules for dogs
CREATED IN ERROR - ATOPLUS 10 mg capsule molli per cani
Active substance:
  • Ciclosporin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ciclosporin
    10.00
    milligram(s)
    /
    1.00
    Capsule
Pharmaceutical form:
  • Capsule, soft
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QL04AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Italy
Package description:
  • Box containing 60 capsules in 12 aluminium/aluminium blister packs
  • Box containing 30 capsules in 6 aluminium/aluminium blister packs
  • Box containing 15 capsules in 3 aluminium/aluminium blister packs

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • Ministry Of Health
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0880/001

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 20/06/2022
Updated on: 21/06/2022
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